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1.
Semin Thromb Hemost ; 2024 Jan 04.
Article in English | MEDLINE | ID: mdl-38176425

ABSTRACT

The inferior vena cava (IVC) and superior vena cava are the main conduits of the systemic venous circulation into the right atrium. Developmental or procedural interruptions of vena cava might predispose to stasis and deep vein thrombosis (DVT) distal to the anomaly and may impact the subsequent rate of pulmonary embolism (PE). This study aimed to review the various etiologies of developmental or procedural vena cava interruption and their impact on venous thromboembolism. A systematic search was performed in PubMed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines per each clinical question. For management questions with no high-quality evidence and no mutual agreements between authors, Delphi methods were used. IVC agenesis is the most common form of congenital vena cava interruption, is associated with an increased risk of DVT, and should be suspected in young patients with unexpected extensive bilateral DVT. Surgical techniques for vena cava interruption (ligation, clipping, and plication) to prevent PE have been largely abandoned due to short-term procedural risks and long-term complications, although survivors of prior procedures are occasionally encountered. Vena cava filters are now the most commonly used method of procedural interruption, frequently placed in the infrarenal IVC. The most agreed-upon indication for vena cava filters is for patients with acute venous thromboembolism and coexisting contraindications to anticoagulation. Familiarity with different forms of vena cava interruption and their local and systemic adverse effects is important to minimize complications and thrombotic events.

2.
J Vasc Interv Radiol ; 34(10): 1658-1663, 2023 10.
Article in English | MEDLINE | ID: mdl-37394033

ABSTRACT

The 2015 Research Consensus Panel (RCP) on submassive pulmonary embolism (PE) set priorities for research in submassive PE and identified a rigorous randomized trial of catheter-directed therapy plus anticoagulation versus anticoagulation alone as the highest research priority. This update, written 8 years after the RCP was convened, describes the current state of endovascular PE practice and the Pulmonary Embolism-Thrombus Removal with Catheter-Directed Therapy trial, the main output from the RCP.


Subject(s)
Fibrinolytic Agents , Pulmonary Embolism , Humans , Fibrinolytic Agents/therapeutic use , Thrombolytic Therapy/adverse effects , Consensus , Pulmonary Embolism/therapy , Pulmonary Embolism/drug therapy , Treatment Outcome , Anticoagulants/therapeutic use
3.
J Vasc Interv Radiol ; 34(2): 284-299.e7, 2023 02.
Article in English | MEDLINE | ID: mdl-36375763

ABSTRACT

PURPOSE: To establish the updated position of the Society of Interventional Radiology (SIR) on the endovascular management of acute iliofemoral deep vein thrombosis (DVT). MATERIALS AND METHODS: A multidisciplinary writing group with expertise in treating venous diseases was convened by SIR. A comprehensive literature search was conducted to identify studies on the topic of interest. Recommendations were drafted and graded according to the updated SIR evidence grading system. A modified Delphi technique was used to achieve consensus agreement on the recommendation statements. RESULTS: A total of 84 studies, including randomized trials, systematic reviews and meta-analyses, prospective single-arm studies, and retrospective studies were identified and included in the review. The expert writing group developed 17 recommendations that pertain to the care of patients with acute iliofemoral DVT with the use of endovascular venous interventions. CONCLUSIONS: SIR considers endovascular thrombus removal to be an acceptable treatment option in selected patients with acute iliofemoral DVT. Careful individualized risk assessment, high-quality general DVT care, and close monitoring during and after procedures should be provided.


Subject(s)
Endovascular Procedures , Venous Thrombosis , Humans , Endovascular Procedures/methods , Femoral Vein/diagnostic imaging , Iliac Vein/diagnostic imaging , Prospective Studies , Radiology, Interventional , Retrospective Studies , Thrombolytic Therapy , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy
4.
J Vasc Interv Radiol ; 34(10): 1643-1657.e6, 2023 10.
Article in English | MEDLINE | ID: mdl-37330211

ABSTRACT

PURPOSE: To state the position of the Society of Interventional Radiology (SIR) on the endovascular management of chronic iliofemoral venous obstruction with metallic stents. MATERIALS AND METHODS: A multidisciplinary writing group with expertise in treating venous disease was convened by SIR. A comprehensive literature search was conducted to identify studies on the topic of interest. Recommendations were drafted and graded according to the updated SIR evidence grading system. A modified Delphi technique was used to achieve consensus agreement on the recommendation statements. RESULTS: A total of 41 studies, including randomized trials, systematic reviews and meta-analyses, prospective single-arm studies, and retrospective studies were identified. The expert writing group developed 15 recommendations on the use of endovascular stent placement. CONCLUSIONS: SIR considers the use of endovascular stent placement for chronic iliofemoral venous obstruction to be likely to help selected patients, but the risks and benefits have not been fully quantified in well-designed randomized studies. SIR recommends urgent completion of such studies. In the meantime, careful patient selection and optimization of conservative therapy are recommended prior to stent placement, with attention to appropriate stent sizing and quality procedural technique. The use of multiplanar venography with intravascular ultrasound is suggested in diagnosing and characterizing obstructive iliac vein lesions and in guiding stent therapy. After stent placement, SIR recommends close patient follow-up to ensure optimal antithrombotic therapy, durable symptom response, and early identification of adverse events.


Subject(s)
Endovascular Procedures , Vascular Diseases , Humans , Retrospective Studies , Prospective Studies , Radiology, Interventional , Treatment Outcome , Femoral Vein/diagnostic imaging , Vascular Diseases/diagnostic imaging , Vascular Diseases/therapy , Vascular Diseases/etiology , Stents , Iliac Vein , Endovascular Procedures/adverse effects , Vascular Patency
5.
J Vasc Interv Radiol ; 33(10): 1161-1170.e11, 2022 10.
Article in English | MEDLINE | ID: mdl-35803552

ABSTRACT

PURPOSE: To identify the baseline patient characteristics that predict who will benefit from pharmacomechanical catheter-directed thrombolysis (PCDT) of acute iliofemoral deep vein thrombosis (DVT). MATERIALS AND METHODS: In the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) multicenter randomized trial, 381 patients with acute iliofemoral DVT underwent PCDT and anticoagulation or anticoagulation alone. The correlations between baseline factors and venous clinical outcomes were evaluated over 24 months using post hoc regression analyses. Interaction terms were examined to evaluate for differential effects by treatment arm. RESULTS: Patients with clinically severe DVT (higher baseline Villalta score) experienced greater effects of PCDT in improving 24-month venous outcomes, including moderate or severe postthrombotic syndrome (PTS) (odds ratios [ORs] and 95% confidence intervals [CIs] per unit increase in the baseline Villalta scores were as follows: for PCDT, OR, 1.08 [95% CI, 1.01-1.15]; for control, OR, 1.20 [95% CI, 1.12-1.29]; Pinteraction = .03), PTS severity (between-arm differences in the Villalta [Pinteraction = .004] and Venous Clinical Severity Scale [VCSS] [Pinteraction = .002)] scores), and quality of life (between-arm difference in the Venous Insufficiency Epidemiological and Economic Study Quality of Life score; Pinteraction = .025). Patients with previous DVT had greater effects of PCDT on 24-month PTS severity than those in patients without previous DVT (mean [95% CI] between-arm difference in the Villalta score, 4.2 [1.56-6.84] vs 0.9 [-0.44 to 2.26], Pinteraction = .03; mean [95% CI] between-arm difference in the VCSS score, 2.6 [0.94-4.21] vs 0.3 [-0.58 to 1.14], Pinteraction = .02). The effects of PCDT on some but not all outcomes were greater in patients presenting with left-sided DVT (Villalta PTS severity, Pinteraction = .04; venous ulcer, Pinteraction = .0499) or a noncompressible popliteal vein (PTS, Pinteraction = .02). The effects of PCDT did not vary by sex, race, ethnicity, body mass index, symptom duration, hypertension, diabetes, or hypercholesterolemia. CONCLUSIONS: In patients with acute iliofemoral DVT, greater presenting clinical severity (higher baseline Villalta score) and a history of previous DVT predict enhanced benefits from PCDT.


Subject(s)
Postthrombotic Syndrome , Venous Thrombosis , Anticoagulants , Catheters , Fibrinolytic Agents , Humans , Iliac Vein/diagnostic imaging , Popliteal Vein , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/therapy , Quality of Life , Thrombolytic Therapy/adverse effects , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy
6.
J Vasc Interv Radiol ; 33(5): 593-602, 2022 05.
Article in English | MEDLINE | ID: mdl-35489789

ABSTRACT

Minority patients such as Blacks, Hispanics, and Native Americans are disproportionately impacted by critical limb ischemia and amputation due to multiple factors such as socioeconomic status, type or lack of insurance, lack of access to health care, capacity and expertise of local hospitals, prevalence of diabetes, and unconscious bias. The Society of Interventional Radiology Foundation recognizes that it is imperative to close the disparity gaps and funded a Research Consensus Panel to prioritize a research agenda. The following research priorities were ultimately prioritized: (a) randomized controlled trial with peripheral arterial disease screening of at-risk patients with oversampling of high-risk racial groups, (b) prospective trial with the introduction of an intervention to alter a social determinant of health, and (c) a prospective trial with the implementation of an algorithm that requires criteria be met prior to an amputation. This article presents the proceedings and recommendations from the panel.


Subject(s)
Peripheral Arterial Disease , Radiology, Interventional , Amputation, Surgical , Chronic Limb-Threatening Ischemia , Consensus , Humans , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/surgery , Prospective Studies , Racial Groups , Research
7.
J Vasc Interv Radiol ; 33(1): 78-85, 2022 01.
Article in English | MEDLINE | ID: mdl-34563699

ABSTRACT

The optimal medical management of patients following endovascular deep venous interventions remains ill-defined. As such, the Society of Interventional Radiology Foundation (SIRF) convened a multidisciplinary group of experts in a virtual Research Consensus Panel (RCP) to develop a prioritized research agenda regarding antithrombotic therapy following deep venous interventions. The panelists presented the gaps in knowledge followed by discussion and ranking of research priorities based on clinical relevance, overall impact, and technical feasibility. The following research topics were identified as high priority: 1) characterization of biological processes leading to in-stent stenosis/rethrombosis; 2) identification and validation of methods to assess venous flow dynamics and their effect on stent failure; 3) elucidation of the role of inflammation and anti-inflammatory therapies; and 4) clinical studies to compare antithrombotic strategies and improve venous outcome assessment. Collaborative, multicenter research is necessary to answer these questions and thereby enhance the care of patients with venous disease.


Subject(s)
Radiology, Interventional , Vascular Diseases , Consensus , Humans , Research , Vascular Diseases/diagnostic imaging , Vascular Diseases/therapy , Vascular Surgical Procedures
8.
J Vasc Interv Radiol ; 32(9): 1296-1309.e7, 2021 09.
Article in English | MEDLINE | ID: mdl-34119655

ABSTRACT

PURPOSE: To describe the clinical outcomes of a pharmacomechanical catheter-directed venous thrombolysis (PCDT) strategy that included AngioJet rheolytic thrombectomy. METHODS: In the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis multicenter randomized trial, physicians at 33 sites designated AngioJet as their preferred device for PCDT. In these sites, 364 patients with acute proximal lower-extremity deep vein thrombosis (DVT) were randomized to a strategy of PCDT that incorporated either AngioJet along with anticoagulation or anticoagulation alone. Relief from presenting DVT symptoms was evaluated over 30 days of follow-up. Postthrombotic syndrome (PTS), quality of life (QOL), recurrent venous thromboembolism (VTE), and safety were evaluated over 24 months of follow-up. RESULTS: Within 30 days, AngioJet-PCDT led to a greater improvement in leg swelling (mean difference calf circumference 0.55 cm, P = .009), venous QOL (mean difference 6.5 Venous Insufficiency Epidemiologic and Economic Study [VEINES]-QOL points, P = .0073), and venous symptoms (mean difference 5.6 VEINES-symptoms points, P = .0134) than control, with differences most apparent in iliofemoral DVT. AngioJet-PCDT reduced PTS at 6 months (24% with AngioJet-PCDT vs 40% with control, P = .003) but did not influence PTS or QOL between 12 and 24 months. Major bleeding, pulmonary embolism, renal failure, and bradycardia were infrequent with AngioJet-PCDT (<2% each), but 24-month VTE recurrence may have been more frequent (13.9% with AngioJet-PCDT vs 6.8% with control, P = .03) CONCLUSIONS: In patients with acute proximal DVT, a treatment strategy that included first-line AngioJet-PCDT was reasonably safe and led to an improved symptom status and venous QOL at 1 month and reduced PTS at 6 months compared with anticoagulation alone. However, AngioJet-PCDT did not influence PTS or the QOL beyond 6 months and may have increased recurrent VTE.


Subject(s)
Quality of Life , Thrombolytic Therapy , Catheters , Femoral Vein , Fibrinolytic Agents/adverse effects , Humans , Thrombectomy , Thrombolytic Therapy/adverse effects , Time Factors , Treatment Outcome
9.
Vasc Med ; 26(6): 662-669, 2021 12.
Article in English | MEDLINE | ID: mdl-34606385

ABSTRACT

Catheter-directed thrombolysis (CDT) has been utilized as an adjunct to anticoagulant therapy in selected patients with deep vein thrombosis (DVT) for approximately 30 years. CDT used to be limited to patients with DVT causing acute limb threat and those exhibiting failure of initial anticoagulation, but has expanded over time. Randomized trials evaluating the first-line use of CDT for proximal DVT have demonstrated that CDT does not produce a major reduction in the occurrence of post-thrombotic syndrome (PTS) and that it is poorly suited for elderly patients and those with limited thrombus extent or major risk factors for bleeding. However, CDT does offer selected patients with acute iliofemoral DVT improvement in reducing early DVT symptoms, in achieving reduction in PTS severity, and in producing an improvement in health-related quality of life (QOL). Clinical practice guidelines from medical and surgical societies are now largely aligned with the randomized trial results. This review offers the reader an update on the results of recently completed clinical trials, and additional guidance on appropriate selection of patients with DVT for catheter-directed thrombolytic therapy.


Subject(s)
Postthrombotic Syndrome , Venous Thrombosis , Aged , Catheters , Humans , Iliac Vein , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/prevention & control , Quality of Life , Thrombolytic Therapy/adverse effects , Thrombolytic Therapy/methods , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/drug therapy
10.
Transfus Med ; 31(4): 292-302, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33955079

ABSTRACT

BACKGROUND: This study was designed to prospectively evaluate the efficacy of extracorporeal photopheresis (ECP) to attenuate the rate of decline of FEV1 in lung transplant recipients with refractory bronchiolitis obliterans. Due to an observed higher than expected early mortality, a preliminary analysis was performed. STUDY DESIGN AND METHODS: Subjects from 10 lung transplant centres were assigned to ECP treatment or to observation based on spirometric criteria, with potential crossover for those under observation. The primary endpoint of this study was to assess response to ECP (i.e., greater than a 50% decrease in the rate of FEV1 decline) before and 6 months after initiation of ECP. Mortality was also evaluated 6 and 12 months after enrolment as a secondary endpoint. RESULTS: Of 44 enrolled subjects, 31 were assigned to ECP treatment while 13 were initially assigned to observation on a non-random basis using specific spirometric inclusion criteria (seven of the observation patients subsequently crossed over to receive ECP). Of evaluable patients, 95% of patients initially assigned to treatment responded to ECP with rates of FEV1 decline that were reduced by 93% in evaluable ECP-treated patients. Mortality rates (percentages) at 6 and 12 months after enrolment was 32% and 41%, respectively. The most common (92%) primary cause of death was respiratory or graft failure. Significantly (p = 0.002) higher rates of FEV1 decline were observed in the non-survivors (-212 ± 177 ml/month) when compared to the survivors (-95 ± 117 ml/month) 12 months after enrolment. In addition, 18 patients with bronchiolitis obliterans syndrome (BOS) diagnosis within 6 months of enrolment had lost 38% of their baseline lung function at BOS diagnosis and 50% of their lung function at enrolment. CONCLUSIONS: These analyses suggest that earlier detection and treatment of BOS should be considered to appreciate improved outcomes with ECP.


Subject(s)
Bronchiolitis Obliterans , Lung Transplantation , Photopheresis , Allografts , Bronchiolitis Obliterans/therapy , Humans , Lung
11.
Circulation ; 139(9): 1162-1173, 2019 02 26.
Article in English | MEDLINE | ID: mdl-30586751

ABSTRACT

BACKGROUND: The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis. METHODS: Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes. RESULTS: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21). CONCLUSIONS: In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.


Subject(s)
Anticoagulants/adverse effects , Endovascular Procedures/adverse effects , Femoral Vein/surgery , Iliac Vein/surgery , Mechanical Thrombolysis/adverse effects , Postthrombotic Syndrome/epidemiology , Acute Disease , Adult , Anticoagulants/administration & dosage , Female , Humans , Male , Middle Aged , Postthrombotic Syndrome/etiology
12.
N Engl J Med ; 377(23): 2240-2252, 2017 12 07.
Article in English | MEDLINE | ID: mdl-29211671

ABSTRACT

BACKGROUND: The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome. METHODS: We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up. RESULTS: Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups. CONCLUSIONS: Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).


Subject(s)
Anticoagulants/therapeutic use , Postthrombotic Syndrome/prevention & control , Thrombolytic Therapy/methods , Tissue Plasminogen Activator/administration & dosage , Venous Thrombosis/drug therapy , Adult , Anticoagulants/adverse effects , Catheterization, Peripheral , Female , Hemorrhage/etiology , Humans , Incidence , Intention to Treat Analysis , Male , Middle Aged , Postthrombotic Syndrome/epidemiology , Postthrombotic Syndrome/etiology , Recombinant Proteins/therapeutic use , Risk Factors , Thrombolytic Therapy/adverse effects , Tissue Plasminogen Activator/adverse effects , Venous Thrombosis/complications
13.
Blood ; 131(7): 733-740, 2018 02 15.
Article in English | MEDLINE | ID: mdl-29295847

ABSTRACT

Patients who present with severe manifestations of acute venous thromboembolism (VTE) are at higher risk for premature death and long-term disability. In recent years, catheter-based interventional procedures have shown strong potential to improve clinical outcomes in selected VTE patients. However, physicians continue to be routinely faced with challenging decisions that pertain to the utilization of these risky and costly treatment strategies, and there is a relative paucity of published clinical trials with sufficient rigor and directness to inform clinical practice. In this article, using 3 distinct clinical scenario presentations, we draw from the available published literature describing the natural history, pathophysiology, treatments, and outcomes of VTE to illustrate the key factors that should influence clinical decision making for patients with severe manifestations of deep vein thrombosis and pulmonary embolism. The results of a recently completed pivotal multicenter randomized trial are also discussed.


Subject(s)
Catheter Ablation/methods , Venous Thromboembolism/surgery , Catheter Ablation/adverse effects , Catheters/classification , Catheters/standards , Clinical Decision-Making , Humans , Patient Selection , Venous Thromboembolism/physiopathology
14.
J Vasc Interv Radiol ; 31(10): 1517-1528.e2, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32948386

ABSTRACT

PURPOSE: To evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT). MATERIALS AND METHODS: Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multicenter randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale. The physician operators recorded their visual assessments of thrombus regression and venous flow. These immediate post-procedure results were correlated with patient outcomes at 1, 12, and 24 months. RESULTS: PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments). At procedure end, spontaneous venous flow was present in 99% of iliofemoral venous segments and in 89% of femoral-popliteal venous segments. For the overall proximal DVT population, and for the femoral-popliteal DVT subgroup, post-PCDT thrombus volume did not correlate with 1-month or 24-month outcomes. For the iliofemoral DVT subgroup, over 1 and 24 months, symptom severity scores were higher (worse), and venous disease-specific quality of life (QOL) scores were lower (worse) in patients with greater post-PCDT thrombus volume, with the difference reaching statistical significance for the 24-month Villalta post-thrombotic syndrome (PTS) severity score (P = .0098). Post-PCDT thrombus volume did not correlate with 12-month valvular reflux. CONCLUSIONS: PCDT successfully removes thrombus in acute proximal DVT. However, the residual thrombus burden at procedure end does not correlate with the occurrence of PTS during the subsequent 24 months. In iliofemoral DVT, lower residual thrombus burden correlates with reduced PTS severity and possibly also with improved venous QOL and fewer early symptoms.


Subject(s)
Femoral Vein , Fibrinolytic Agents/administration & dosage , Iliac Vein , Popliteal Vein , Thrombolytic Therapy , Tissue Plasminogen Activator/administration & dosage , Venous Thrombosis/therapy , Adolescent , Adult , Aged , Female , Femoral Vein/diagnostic imaging , Fibrinolytic Agents/adverse effects , Humans , Iliac Vein/diagnostic imaging , Male , Middle Aged , Phlebography , Popliteal Vein/diagnostic imaging , Postthrombotic Syndrome/etiology , Thrombolytic Therapy/adverse effects , Time Factors , Tissue Plasminogen Activator/adverse effects , Treatment Outcome , United States , Venous Thrombosis/complications , Venous Thrombosis/diagnostic imaging , Young Adult
15.
Vasc Med ; 24(5): 442-451, 2019 10.
Article in English | MEDLINE | ID: mdl-31354089

ABSTRACT

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, p = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, p < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, p = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; p = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, p = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. ClinicalTrials.gov Identifier NCT00790335.


Subject(s)
Catheterization, Peripheral , Fibrinolytic Agents/administration & dosage , Thrombolytic Therapy , Ultrasonography, Doppler, Duplex , Venous Thrombosis/therapy , Administration, Intravenous , Adult , Catheterization, Peripheral/adverse effects , Female , Fibrinolytic Agents/adverse effects , Humans , Male , Middle Aged , North America , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/physiopathology , Predictive Value of Tests , Quality of Life , Risk Factors , Severity of Illness Index , Thrombolytic Therapy/adverse effects , Time Factors , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/physiopathology
16.
Transfusion ; 58(12): 2933-2941, 2018 12.
Article in English | MEDLINE | ID: mdl-30312482

ABSTRACT

BACKGROUND: The most common instruments used for extracorporeal photopheresis (ECP) treatment in the United States are the UVAR XTS and the CELLEX devices (Therakos, West Chester, PA). When compared to the UVAR XTS instrument, the efficacy of the CELLEX instrument to arrest the decline in lung function in patients with chronic lung allograft dysfunction (CLAD) related to bronchiolitis obliterans (BOS) has not been previously evaluated. METHODS: The relative efficacy of the CELLEX vs UVAR XTS ECP instruments was assessed by comparing the difference in rates of FEV1 decline before and after ECP treatment and survival in two series of lung allograft recipients with BOS who had been treated with these instruments. RESULTS: Similar Slope Difference values for change in rate of decline (6 months Post ECP - Pre ECP) were observed between the two cohorts (UVAR XTS: 85 ± 109 mL/month vs CELLEX: 76 ± 128 mL/month, p=0.72). A similar percentage of patients responded to ECP (UVAR XTS: 77% vs CELLEX: 89%; p=0.36) i.e., as defined as a positive difference in slope between the rate of decline of FEV1 before and 6 months after ECP. Survival at either 6 (p=0.89) or 12 (p=0.8) months after the start of ECP was not associated with instrument used despite a trend in higher early mortality (34% vs 17%, p=0.054) in the patients who were predominately treated with the CELLEX. CONCLUSIONS: Our data support the use of the CELLEX for prospective studies designed to evaluate the merits of ECP in this population.


Subject(s)
Bronchiolitis Obliterans/therapy , Lung Transplantation , Photopheresis/instrumentation , Adult , Aged , Allografts , Female , Humans , Male , Middle Aged , Photopheresis/methods
20.
Vasc Med ; 21(5): 459-466, 2016 10.
Article in English | MEDLINE | ID: mdl-27178760

ABSTRACT

Patients with inferior vena cava (IVC) filter-associated deep venous thrombosis (DVT) are a challenging subset of patients for endovascular intervention. Given the lack of available data pertaining to this clinical scenario, the purpose of this study was to evaluate the authors' experience with the use of endovascular treatment for DVT in patients with IVC filters. Primary aims included assessing the technical and clinical success, complications, and clinical patency in these patients. This was a retrospective single-center review of adult patients with IVC filters undergoing endovascular treatment of DVT between 1/2005 and 4/2014. Patient electronic medical records were reviewed for demographic data, anticoagulation status, symptoms, symptomatic extremities, extent of thrombosis, therapies received, technical and clinical success, and complications. Query yielded 82 patients (mean 53 years, range 18-96; 66% male), all of whom were included in our analysis. The majority of patients presented with lower extremity pain and swelling, with extensive clot burden despite the use of anticoagulant medication. Treatment elements utilized included pharmacologic lysis in 92%, mechanical thrombectomy in 77%, angioplasty in 63% and stent placement in 50% of patients. Interventions were technically successful in restoring flow in 87% of patients, and clinically successful in improving presenting symptoms in 79% of patients. By SIR criteria, 24% of patients experienced complications (categorized as 10% minor and 14% major). There were two deaths from intracranial hemorrhage. The probability of thrombosis-free survival at 1, 3, 6, 9 and 12 months was 0.85 (CI 0.74-0.93), 0.81 (CI 0.69-0.89), 0.74 (CI 0.62-0.83), 0.70 (CI 0.57-0.8) and 0.70 (CI 0.57-0.8), respectively. Endovascular interventions are usually effective in relieving symptoms in patients with DVT and pre-existing IVC filters. However, these outcomes are achieved with significant complication rates that may exceed those observed when endovascular therapy is provided for other DVT populations.


Subject(s)
Vena Cava Filters/adverse effects , Venous Thrombosis/therapy , Adolescent , Adult , Aged , Aged, 80 and over , Disease-Free Survival , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Missouri , Phlebography , Prosthesis Design , Retrospective Studies , Risk Factors , Stents , Time Factors , Treatment Outcome , Vascular Patency , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/etiology , Venous Thrombosis/physiopathology , Young Adult
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